COMMENTS AND RESPONSE TO COMMENTS ON ANNEX XV SVHC : PROPOSAL AND JUSTIFICATION

Substance name:	1,2,4 Trichlorobenzene	
CAS number:	120-82-1	
EC number:	204-428-0	

Reason of the submission of the Annex XV: PBT like substance, (equivalent level of concern)

Disclaimer: The European Chemicals Agency is not responsible for the content of this document. The Response to Comments table has been prepared by the competent authority of the Member State preparing the proposal for identification of a Substance of Very High Concern. The comments were received during the public consultation of the Annex XV dossier.
The table does not contain any confidential information.

General comments
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
1	2010-10-14	International NGO,
Health and Environment Alliance,
Belgium	We support the inclusion of 1,2,4 Trichlorobenzene on the candidate list on the basis of the information in the Annex XV dossier	Thank you for your support.	
2	2010-10-14	National NGO,
Friends of the Earth Germany / BUND,
Germany	First, Friends of the Earth Germany / Bund fur Umwelt und Naturschutz Deutschland as one of the major environmental NGOs working on REACH implementation in Germany, would like to thank ECHA for the opportunity to comment on the SVHC proposals.   The number of chemical substances on the candidate list is still below what we expected and what would be needed for the effective substitution of at least the most important chemicals of very high concern. It is essential, that, besides CMR-substances, PBT and PBT-like chemicals with relevant environmental risk potential are included in the candidate list.  We support the German proposal to put Trichlorobenzenes as SVHC on the candidate list according to REACH Article 57f.   	Thank you for your support.	
3	2010-10-14	MSCA,
United Kingdom 	Please note these comments apply to all 3 dossiers.  We welcome the approach to grouping/read-across for the less studied isomers, and only had a few general comments. Are any data available for tetra- and pentachlorobenzenes? More discussion could have been added about the apparent trend in solubility and vapour pressure, and how these might affect environmental behaviour. Also, it is not always clear whether the reliability of the data for these isomers has been assessed. The data for 1,2,3- and 1,3,5-TCB could have been mentioned in the conclusions for 1,2,4-TCB as part of a true grouping approach. We note that the log Kow value cited for 1,2,4-TCB in the data matrix does not match the one given in the dossier for that substance.  The summary conclusion (page 3 of the Annex XV reports) refers to the previous TCNES PBT Working Group conclusion that 1,2,4- and 1,2,3-TCB were identified as PBT substances. Whilst it is appropriate to reflect previous conclusions on these substances in the dossiers, we think it should be deleted from this summary section as the actual conclusion of the dossier is that the substances are of “equivalent concern”. 	Except for the estimation of atmospheric half-life, read-across was carried out with the trichlorobenzenes exclusively. 
To our knowledge, there are no data available for the atmospheric degradation of tetra- and pentachlorobenzenes.
There may be available data for other properties, but there is no European Risk Assessment Report on these substances and a detailed evaluation of these data would have gone beyond the scope of these dossiers. 
Thank you for your hints. We have considered them in the dossiers.	
4	2010-10-14	International NGO,
WWf European Policy Office,
Belgium	WWF and CHEM Trust support the inclusion of 1,2,4 trichlorobenzene in the candidate list as chemical of equivalent concern due to its PBT-like properties.	Thank you for your support.	
5	2010-10-14	National Authority,
RIVM,
Netherlands	We would like to note that from a principle point of view a substance can not be classified both as a PBT substance and as a substance of equivalent concern as mentioned in the summary. Based on the data it is not appropriate to conclude that 1,2,4-trichlorobenzene is a PBT substance as both the B and T criteria are not fulfilled.   We do agree that the substance fulfils the P and vP-criteria and has the potential for long-range environmental transport. However, after further consideration, as outlined below, we believe that the available data on the bioaccumulation potential and toxicity of 1,2,4-trichlorobenzene does also not justify the conclusion that the substance has properties of equivalent concern according to Article 57(f).  	Thank you for your hints. We have considered them in the updated dossiers. We have both updated the chapter on bioaccumulation and given a more detailed rationale for 57f.	
6	2010-10-14	European institution,
European Chemicals Agency,
Finland	It has been proposed to identify 1,2,4-Trichlorobenzene as a substance giving rise to an equivalent level of concern in accordance with Article 57 (f) of the REACH Regulation on the basis of the information available on its persistent, bioaccumulative and toxic properties and on its long-range transport potential. Article 57 (f) serves as a kind of “safety net” for covering any substance properties that could give rise to an equivalent level of (very high) concern in relation to the properties addressed in Article 57 (a) to 57 (e). Therefore, circumstances and considerations to be taken into account when deciding on whether a substance gives rise to an equivalent level of concern as set out in Article 57(f) can be very diverse and appear not to allow the definition of a generally applicable set of criteria. Consequently, Article 57 (f) requests a case by case consideration. To allow this, the Member State Committee should discuss for all three trichlorobenzene isomers whether it considers the information available sufficiently conclusive to identify these isomers as meeting the “equivalent concern” definition set out in Article 57 (f) and record carefully in the agreement documents the arguments applying for its conclusion.  In our opinion, the argumentation brought forward in the Annex XV dossier appears not to be fully adequate to allow a decision on whether 1,2,4-TCB can be identified as a SVHC in accordance with Art. 57 (f). 	Thank you for your hints. We have considered them in the updated dossiers. We have both updated the chapter on bioaccumulation and given a more detailed rationale for 57f.	
7	2010-10-13	National Authority,
Climate and Pollution Agency,
Norway	The Norwegian CA supports that 1,2,3-Trichlorobenzene (CAS number 87-61-6), 1,2,4-Trichlorobenzene (CAS number 120-82-1) and  1,3,5-Trichlorobenzene (CAS number 108-70-3)  should be identified as substances of very high concern and should be included in the Candidate List.	Thank you for your support.	
8	2010-10-13	International NGO,
International chemical secretariat,
Sweden	Full support regarding its identification as a SVHC.   	Thank you for your support.	
9	2010-10-13	Company,
Germany	It is proposed not to identify the substance as substance of equivalent concern according to Article 57 (f).  Though the substance is considered to fulfill the P criterion and the B criterion can be seen as scarcely fulfilled, in case that lipid normalization is not performed, 1,2,4-trichlorobenzene does not fulfill the T criterion according Annex XIII, REACH. Therefore 1,2,4-trichlorobenzene is no PBT substance according Annex XIII, REACH. The proposing Member State Competent Authority does not quote concrete other probable serious effects to human health or the environment with scientific evidence which give rise to an equivalent level of concern to those of other substances listed according points (a) to (e) of Article 57, REACH.	Thank you for your comments. We have considered them in the updated dossiers. We have both updated the chapter on bioaccumulation and given a more detailed rationale for 57f..	
10	2010-10-11	Company,
LANXESS Deutschland GmbH,
Germany	Following a REACH Annex XV report, 1,2,4-TCB has been proposed for identification as substance with an “equivalent level of concern as PBT substances”. It is disputable if the existing data justify this classification. The B- and the T-criterion are formally not met. The P-criterion may be fulfilled for soils. Additionally persistence in air and LRT are taken into account. Although the substance has potential to persist in air, this criterion only supports the indication of 1,2,4-TCB as “P” or “equivalent to P”. Available monitoring data provide evidence that exposure is low.   Taking into account the current registration status under REACH and thereby, the current restricted use pattern (only 1 European producer, only as intermediate in closed systems and strictly controlled conditions with certificates from all customers within and outside the EU) as well as the latest monitoring data we are convinced that the identification of 1,2,4-Trichlorobenzene as a Substance of Very High Concern is not necessary. There are no uses in Europe to justify the identification as SVHC. 	Thank you for your comments. We have considered them in the updated dossiers. We have both updated the chapter on bioaccumulation and given a more detailed rationale for 57f. The exposure is not relevant for this type of dossier. 	
11	2010-10-06	National Authority,
Allgemeine Unfallversicherungsanstalt,
Austria	We support 1,2,4-Trichlorobenzene to be placed on the candidate list. Following the Annex XV report is mainly used as an intermediate and therefore expect that it will be registrated as an intermediate. This Trichlorobenzene isomer is also used as a process solvent that means under strictly controlled conditions. We recommend to keep this in mind when discussing the inclusion in the authorisation process. Furthermore to authorise solely these uses that have to fulfill all requirements of art. 17 or art. 18 of the REACH regulation. 	Thank you for your support. We have considered your hint in the dossier.	
12	2010-10-06	MSCA,
Sweden	Sweden supports the proposal to identify 1,2,4 Trichlorobenzene as a substance of very high concern.	Thank you for your support.	
13	2010-09-03	Trade union,
European Trade Union confederation,
Belgium	ETUC supports the inclusion of 1,2.4 trichlorobenzene in the Candidate List.	Thank you for your support.	
14	2010-09-03	MSCA,
Spain	From our point of view the dossier is very complet, this chemical was classified previously as equivalent concern by the European TCNES Subgroup on Identification of PBT Substances so the inclusion of this chemical as PBT/vPvB and equivalent level of concern is fully supported.	Thank you for your support.	

Specific comments on the justification
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
15	2010-10-14	National NGO,
Friends of the Earth Germany / BUND,
Germany	The T criterion for PBT may not be met, nevertheless the properties of these chemicals are very close to fulfilling the given criteria. Trichlorobenzenes are still found in surface waters in relevant concentrations and are ubiquitous contaminants. It appears to be very reasonable to consider the “equivalent concern” route, as trichlorobenzenes fulfill the P- and B-criteria and in addition have a very high potential for long-range transport via air. The PBT Working Group of the formerly known European Chemicals Bureau therefore stated that 1,2,3-TCB and 1,2,4-TCB should be considered as PBT-substances.  Long-range transport occurs in the case of volatile and persistent substances and leads to global distillation processes, i.e. relatively high concentrations of the chemical in arctic and antarctic regions. Due to the low temperature in these areas, biodegradation is significantly lowered, thereby accumulation and environmental risk increases.  A very high potential for long range transport via air is demonstrated in the Annex XV report, based on physico-chemical data. In addition, publications on Trichlorobenzenes are indicative for the occurrence of such a process: Concentrations of 1,2,4-trichlorobenzene and 1,2,3-trichlorobenzene were shown to be higher in herring from the North Atlantic compared to those from the North Sea, moreover, concentrations in herring from remote deep sea areas were higher than levels found in herring from marine areas close to the coast (Stiehl 2007, see also Norwegian Institute for Water Research, 2005).  Accumulation via global distillation processes is to be seen as a severe threat to the very sensitive polar areas and should be considered as equivalent concern (according to Article 57f) for the environment.  References:  Thorsten Stiehl (2007). Abschlussbericht des Projektes “Globale Destillation. Belastung von Heringen im Nordatlantik, der Nordsee und der Ostsee mit PBT- und vPvB-Substanzen”. http://www.bvl.bund.de/...abschlussbericht_globale_destillation.pdf Norwegian Institute for Water Research (2005). Concentrations and levels of POPs from long-range transboundary air pollution in freshwater fish and sediments. http://www.niva.no/2...079-2005_200dpi.pdf 	Thank you for your comment. We have considered the given details in the dossier.	
16	2010-10-14	MSCA,
United Kingdom	p.10-12, Section 3.1.2.: Although a more detailed description of some of the key studies could be provided (e.g. Bartholomew & Pfaender, 1983 and Pfaender & Bartholomew, 1982), it seems clear that trichlorobenzenes meet the P criterion in various non-adapted environmental compartments. We think it might be helpful to flag the fact that no simulation test performed according to international test guidelines is available, but that the weight of evidence indicates that further testing is unlikely to change the conclusion for this end point. This was done in the original PBT fact sheet prepared by Denmark.  

p. 14, Section 3.2.3: The sensitivity of the modelling to all of the various input parameters should be discussed (as was done in the original PBT fact sheet). It would also be useful to discuss deposition potential, as has been done recently in the evaluations of the organosiloxanes D4 and D5.   

p. 19-21, Section 3.3: None of the substances meets the screening criterion for B based on the octanol-water partition coefficient. Our interpretation of bioconcentration data has moved on since 2003, and the REACH guidance clearly indicates that BCF data should be normalised to a 5% lipid content where possible (and growth corrected too). This has not been done properly in the dossiers. It may be possible to ask the Japanese MITI for information on the lipid content of the carp in the studies they performed, to add further data for this analysis. In addition, the validity of the various studies is ignored in the overall summary of the data - invalid studies should not be considered. So, based on the studies with a reliability of 2 or 4, lipid normalisation shows that the highest BCF is around 1,000, which is well below the B criterion. This should be explicitly stated as the conclusion.   

p. 21, Section 3.3.3: The bioaccumulation summary refers to the “weight of evidence” but this is not in fact presented (e.g. the weightings of the different data, whether confirmatory or otherwise, are not discussed). We note that the PBT fact sheet also referred to field data (BAFs and levels in bird eggs). This is missing from the discussion, and a proper evaluation of this information should be made in the context of Annex XIII. We know that some other volatile substances are not expected to accumulate significantly in air-breathing organisms, so the relevance of the octanol-air partition coefficient should also be considered.   

p.23-26, Section 5: The substances do not meet the T criterion based on either aquatic or mammalian toxicity, as explained in the original PBT fact sheet. The mammalian data set should be briefly summarised for completeness.   

p. 27, Section 6: Based on the data currently presented in the dossiers, the TCBs are not PBT or vPvB substances. The main argument for equivalent concern is based on long-range transport potential (LRTP), which is not mentioned in Annex XIII. The technical guidance on SVHC identification states: “A further example of a substance that could be considered as being of equivalent concern is where one of the PBT or vPvB criteria is marginally not fulfilled but the other criteria are exceeded considerably, and there is other evidence to suggest that the substance gives rise to an equivalent level of concern such as a potential for long-range transport” (emphasis added). We also note that long-range transport is only one of the information considerations under the Stockholm convention. So, as these dossiers are setting a precedent for how to deal with LRTP as an equivalent concern issue, we believe that there needs to be a more thorough discussion of the weight that should be given to it. This is not only a technical matter.  

p.29, Part II (Information on uses): The wording about the role of the Water Framework Directive is not strictly correct - occurrence is detected by monitoring (assuming this actually takes place), but is not controlled by it. We note that the various dossiers have identical text based on 1,2,4-TCB, which is not necessarily relevant for the other isomers. 	Thank you for your comments. We have considered them in the updated dossiers. We have updated the chapter on bioaccumulation and given a more detailed rationale for 57f.

We agree that it would be good to have a short summary on the mammalian dataset; however, this is not essential for this type of dossier. There are different German authorities for environmental and human health effects, respectively, and inclusion of the human health data set requires coordination, thus it is not possible to include that summary in the short timeframe given for the response to comments. However, that summary may be added during the last updates at the MSC in December.
We agree with the comment on monitoring  and the role of the WFD. However, it is not possible to change this part of the dossier in the current procedure. 	
17	2010-10-14	International NGO,
WWf European Policy Office,
Belgium	It is proposed to consider the following studies for inclusion in the dossier to support the presented information regarding the potential for bioaccumulation in wildlife and long range transport:   

Detection in seals, fish and invertebrate: 
D. Muir, T. Savinovab, Vladimir Savinov, Ludmila Alexeeva, Vladimir Potelov, Vladislav Svetochev: Bioaccumulation of PCBs and chlorinated pesticides in seals, fishes and invertebrates from the White Sea, Russia, Sci Total Environ.306, 2003, 111-131.

Detection in polar bears: T.W. Bentzen, D.C.G. Muir, S.C. Amstrup, T.M. O'Harad: Organohalogen concentrations in blood and adipose tissue of Southern Beaufort Polar Bears, Sci Total Environ. 406, 2008, 352-367.  

Detection in fish for consumption from the North and Baltic Sea: T. Stiehl, J. Pfordt, M. Ende, S. Effkemann, R. Kruse, E. Bartelt, W. Peuckert: Anreicherung von “persistenten, bioakkumulierenden, toxischen Substanzen” und von “sehr persistenten, sehr bioakkumulierenden Substanzen” in Heringen aus dem Nordatlantik, der Nordsee bzw. der Ostsee, Journal of Consumer Protection and Food Safety, J. Verbr. Lebensm. 3, 2008, 82 - 94. 	Thank you for your comment.	
18	2010-10-14	National Authority,
RIVM,
Netherlands	Bioaccumulation  
We share the opinion that 1,2,4-Trichlorobenzene is a bioaccumulative substance. However, the valid bioconcentration studies for 1,2,4-Trichlorobenzene do not show bioconcentration factors in excess of 2000, or close to it, when normalized to 5% lipid content as required according to the REACH guidance. Valid BCF values (i.e., those with reliability index 1 or 2) ranged from 120 to 1320. Also the studies which were rated as invalid ( RI of 3 or 4), did not provide BCF values > 2000 when normalized to 5% lipid content. Studies scored as not reliable showed BCF values varied from 783 to 1818.  Moreover, studies where reliability was not assignable showed BCF values between 344-1412. Overall, there is no convincing evidence to believe that the BCF value of 1,2,4-Trichlorobenzene is close to the B-criterion of Annex XIII.   
We recognize that substances with a BCF below the trigger value could still biomagnify in the food web. However, analysis of trichlorobenzenes in different trophic levels showed that both in water-respiring and air-breathing organisms biomagnification was insignificant (ref: Muir D, Savinova T, Savinov V, Alexeeva L, Potelov V, Svetochev V. Bioaccumulation of PCBs and chlorinated pesticides in seals, fishes and invertebrates from the White Sea, Russia. The science of the Total Environment. 2003:306:111-131) and Kelly BC, Ikonomou MG, Blair JD, Morin AE, Gobas FAPC. Food Web-Specific Biomagnification of Persistent Organic Pollutants. Science. 2007:317:236-239.). With respect to air-breathing animals, this can be explained by the fact that the Koa of the trichlorobenzenes is not high enough to cause a slow respiratory elimination. In conclusion, both aquatic BCF values as field BMF values are in support that 1,2,4-Trichlorobenzene does not meet the B-criterion or are of equivalent concern.  

Toxicity  
Although the substance could be classified very toxic (with lowest NOEC values of 0.04, 0.06 and 0.37 mg/L for fish, daphnia and algae, respectively), obviously all toxicity data do not meet the T-criterion and are in the same order of magnitude for different taxonomic groups, indicating a general mode of action due to non-polar narcosis. In addition, no other concerns, like endocrine disruption, are known to consider the substance of equivalent concern according to Article 57(f).  

Emissions and exposure 
The Annex XIV dossier indicates that extensive restrictions exist for 1,2,4 - trichlorobenzene and that the main uses as an intermediate and as a process solvent in closed applications are not considered to result in a release of 1,2,4-TCB into the environment. All other uses are restricted. As stated in the Annex XV dossier, “With regard to the known uses of the three Trichlorobenzenes, current exposure is expected to be low, but trichlorobenzenes should be considered for further regulatory steps due to their SVHC properties.  Our argumentation is the opposite: exposure is relatively low due to the fact that the main uses are as intermediates and process solvents in closed systems.  SVHC properties are not yet a given, but in the case of 57(f), should be shown in by “scientific evidence of probable serious effects to human health or the environment”  In the case of a 57(f ) substance with PBT like properties,  “equivalent level of concern” should be demonstrated by scientific evidence and thus introduces a WoE approach.  

Conclusions in a weight of evidence approach 
Given the fact that the PBT criteria are not fulfilled for the trichlorobenzenes, when the appropriate BCF normalization to 5% lipids is applied, the conclusion on identification as SVHC under Article 57(f) hinges on the quality of the argumentation that these substances are of “equivalent level of concern”. In our view, this should be based on scientific evidence of probable serious effects: how else would we define “substance of very high concern”, in the context of REACH article 57(f)? We conclude that the trichlorobenzenes are substances that have vP properties, but do not meet the B and T criteria. Especially for the B criterion, there are no data that show that these substances are borderline B, nor do they biomagnify in aquatic and terrestrial ecosystems.  The emissions and exposure of these substances are limited due to the current restrictions and types of uses, leading to a low exposure potential. The combination of hazardous properties that are not PBT or borderline PBT, restricted or controlled uses and expected relatively low exposure does not lead to scientific evidence of probable serious effects to human health or the environment that need to be regulated through the status as SVHC under Article 57(f).  
In our view, these substances are not clear candidates for “equivalent level of concern”, under Article 57(f).  	Thank you for your comments. We have considered them in the updated dossiers. We have updated the chapter on bioaccumulation and given a more detailed rationale for 57f.

We have normalized the BCF to 5% lipids in the updated dossier version. For 1,2,4-trichlorobenzene highest reliable BCF of 1140-1320 were reported in the MITI-List, although lipid normalization is not possible because no information on lipid content are provided. 

In addition, a field-study by Burkhard (ETC Vol. 16, 1997, 1677-1686) still indicates a significant potential for bioaccumulation.

We agree with your interpretation that the T criterion is not met. However, the chronic toxicity is close to the trigger value, this has been acknowledged in the dossier.

	
19	2010-10-13	Company,
Germany	The present Annex XV dossier shows reasons for classifying the substance as persistent. This includes its volatility and persistence to atmospheric degradation and its high potential for long-range atmospheric transport. So the substance may be considered to also fulfill the vP-criterion. Nevertheless, this is no additional effect to human health or the environment according Article 57 (f).   
Taking in account bioaccumulation data “reliable without restriction” or “reliable with restriction” only the BCF limit > 2000 is exceeded with 2026 by one study barely (Smith et al., 1990).   
Two other listed studies resulting in a BCF above 2000 (Oliver and Niimi, 1983: BCF = 3200 and Geyer et al., 1985: BCF = 2100) are reported with a reliability of 3. Thus this studies are considered to be invalid and should not be used for risk assessments and regulatory purposes. Furthermore, the BCF data should be normalized to a fat content of 5% (GD R11). However, as assessed in the EU RAR (2003) the biomagnification through the food chain may be low as 1,2,4-Trichlorobenzene shows a rapid depuration in fish and mammals. The substance is classified according Annex VI, CLP and does not meet the criteria according Article 57 a) to c). In such a case NOEC of chronic toxicity studies are required for the assessment of the T-criterion. In the Annex XV dossier non of the values based on valid data on long-term toxicity to aquatic invertebrates and on tests on algae reached the trigger value NOEC below 0.01 mg/l. Than the Guidance on information requirements and chemical safety assessment Part C: PBT Assessment asks for long-term fish studies. For 1,2,4-Trichlorobenzene seven chronic fish studies are available tested on five different fish species. The lowest valid value on long-term toxicity to fish was found with NOEC 0.04 mg/l (Broecker et al., 1984). The NOECs in the other fish studies ranged from 0.11 mg/L to 0.5 mg/L. This does not fulfill the T-criterion. Due to the results of the aquatic toxicity studies and the relevant mammalian toxicity studies the substance is considered to be not toxic (not T). Thus 1,2,4-Trichlorobenzene is neither PBT nor vPvB.	Thank you for your comments. We have considered them in the updated dossiers. We have updated the chapter on bioaccumulation and given a more detailed rationale for 57f.
	
20	2010-10-13	International NGO,
International chemical secretariat,
Sweden	The classification is clearly justified due to its PBT properties and its wide dispersive use.  	Thank you for your comment.	
21	2010-10-12	National Authority,
Health & Safety Authority,
Ireland	The Irish Competent Authority agrees with the identification of 1,2,4-Trichlorobenzene as an SVHC in accordance with Article 57(f) of EU No. 1907/2006. While the substance does not fulfil the T criteria (not less that 0.01 mg/L) and the B criteria in accordance with Annex XIII; the scientific evidence provided indicates that the substance is very toxic to the aquatic environment (NOEC values <1 mg/l for vertebrate and invertebrate species) and has bioaccumulative value (lipid normalised 1818) close to the cut-off value of 2000 for BCF.  In addition, the information provided on persistency in soil is 194 days fulfils the P and vP criteria. Also, in accordance with the Technical Guidance Document (TGD) for PBT assessment, the half life in air shows potential for long range transport (measured value in air is 18.5 days; TGD value > 2 days). Furthermore, the characteristic travel distance (CTD) of this substance is of concern as it is approximately 9000 km.  	Thank you for your supportive comment.	
22	2010-10-11	Company,
LANXESS Deutschland GmbH,
Germany	The Annex XV report submitted by Germany (2010) and the ECB summary fact sheet of the PBT working group (2008) both conclude that the compound is a PBT or PBT-like substance, whereas a marine risk assessment performed by Van Wijk et al. (2006) from Euro Chlor comes to a contradicting conclusion.   

Comments on Part I of the Annex XV Dossier “Justification”  
Fulfilment of PBT criteria  
Toxicity 
With regard to health hazards 1,2,4-trichlorobenzene is only classified as harmful if swallowed (R22) and irritating to skin (R38). Besides the relevant health classification criteria (C or M or R or R48), which are not met, the key threshold criterion for toxicity is a long-term NOEC of < 0.01 mg/L. For 1,2,4-TCB, several valid studies are available on acute and long-term effects of the compound on aquatic organisms. Long term NOECs are available for species from three trophic levels: fish (7x), invertebrates (5x), and algae (5x). Values are within a range of 0.033 mg/L (Mysidopsis bahia) to 3.0 mg/L (Scenedesmus subspicatus).   
For 1,2,4-TCB the T-criterion is not fulfilled.  
Bioaccumulation  
The B-threshold criterion for bioaccumulation is a BCF of > 2000 L/kg. With a log Kow of 4.05 some potential for bioaccumulation is indicated for 1,2,4-TCB. Only two reliable studies are available that give BCF values for fish in the range of 120-1320  (Cyprinus carpio) and 2026 (Jordanella floridae) based on whole body concentrations. Additional but less reliable tests give BCF values in the range of 574-1412. One higher BCF of 3200 was found for fish exposed to a mixture of 12 compounds, but since effects of mixture toxicity on bioaccumulation could not be excluded, this value is not considered valid. When normalised to lipid content, BCF values of 1,2,4-TCB are all below 2000. Additionally, in several studies high elimination rates of 1,2,4-TCB have been found with depuration half lives in fish ranging from 0.2 days to 1.54 days (Kunemann and van Leeuwen, 1980; Smith et al., 1990; Eck et al., 1997). In crustaceans and algae, bioaccumulation is low with BCF values up to 250 (data given in Van Wijk et al., 2006).  
With lipid-normalized BCF values for fish below 2000, and a high elimination rate (depuration half lifes of maximal 1.5 day), the B-criterion is considered not to be fulfilled.    
Monitoring data 
Although theoretically, 1,2,4-TCB can persist for a long time in the environment, available monitoring data show low levels of TCBs. In the Fish Monitoring Program commissioned by the Alaska Department of Environmental Conservation (State of Alaska, 2008), 1,2,4-TCB was detected in 16 of 89 samples with an average concentration of 0.25 ??g/kg ww and a maximum concentration of 0.83 ??g/kg ww. In the other samples, the concentrations were below the detection limit of 0.05 ??g/kg ww. Since trichlorobenzenes are on the priority list of the Water Framework Directive (WFD), monitoring data over several years are available for water bodies in Europe. Based on findings in German water bodies, concentrations of TCBs are decreasing over the years. Since 2001, concentrations of 1,2,4-TCB are below the detection limit of 0.005-0.1 ??g/L in more than 99% of the samples taken from the Rhine in Germany (http://maps.wasserblick.net:8080/iksr-zt/). As shown in the figure below, concentrations on suspended solids were clearly decreasing in the beginning of the 90s and relatively low levels have been measured since 1994. Data are only shown for the sample station Bimmen because here the highest available concentrations were found. In other spots of the Rhine, for example in Weil am Rhein, since 2003 concentrations are below the detection limit of 1 ??g/kg in more than 70% of the samples. Despite the high persistence potential of TCBs, monitoring data demonstrate that, with the current applications, accumulation in the environment does not seem to occur.   

Figure 1. Concentrations of trichlorobenzenes on suspended solids samples from the Rhine (sampling station Bimmen) Source: http://maps.wasserblick.net:8080/iksr-zt/    

Definition of substances with levels of equivalent concern
According to Article 57 (f) of the REACH regulation, it is possible to identify substances to have an “equivalent level of concern” as for example PBT substances. Clear definitions of what “equivalent level of concern” means are not provided by the Regulation or its Guidance Documents. In case of 1,2,4-TCB which does neither fulfil the T- nor the B-criterion, the CA of Germany has regarded the potential for LRT as additional criterion to assign the label of equivalent concern.   
t is however disputable if this criterion is sufficient to classify a substance as equivalent to PBT. One could argue that for those substances which are only partly fulfilling PBT criteria, for each individual criterion (toxicity, bioaccumulation, persistence), additional or substituting criteria could be used to emphasize the concern for P, B or T. In case of the P-criterion it could be a logical and relevant decision to include LRT as additional or substituting criterion for persistence. In the case of 1,2,4-TCB this would mean that the substances can be seen as “P” or “equivalent to P”.  
In contrast, the present data do not give any indication that the substance can be classified as “equivalent to B”. Monitoring data for fish could possibly be used to classify a substance as “equivalent to B”, but in this case measured concentrations in fish rather indicate that the substances are not bioaccumulating.  
Similar as for PBT substances and POP substances, the criterion “persistence” is in our opinion by itself not sufficient to nominate candidates for authorisation.  	Thank you for your comments.
(Ecotoxicity: the T-criterion is not fulfilled even so the substance is toxic.)

We have considered them in the updated dossiers. We have updated the chapter on bioaccumulation and given a more detailed rationale for 57f.
	
23	2010-09-03	Trade union,
European Trade Union confederation,
Belgium	That substance is also included in the TU Priority List for REACH authorisation. see http://www.etuc.org/a/7479	Thank you for your comment.	
24	2010-09-03	MSCA,
Spain	We are in agreement with the German conclusions to include the 1,2,4 trichlorobenzene as PBT/vPvB and equivalent level of concern assessment (pages 27 and 28).	Thank you for your support.	

INFORMATION ON USE, EXPOSURE, ALTERNATIVE AND RISKS ON ANNEX XV SVHC
Substance name:	1,2,4 Trichlorobenzene	
CAS number:	120-82-1	
EC number:	204-428-0	

Reason of the submission of the Annex XV: PBT like substance, (equivalent level of concern)

Disclaimer: The European Chemicals Agency is not responsible for the content of this document. The Response to Comments table has been prepared by the competent authority of the Member State preparing the proposal for identification of a Substance of Very High Concern. The comments were received during the public consultation of the Annex XV dossier.
The table does not contain any confidential information.

Specific comments on use, exposure, alternatives and risks
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
1	2010-10-14	MSCA,
United Kingdom	p.29, Part II (Information on uses): The wording about the role of the Water Framework Directive is not strictly correct - occurrence is detected by monitoring (assuming this actually takes place), but is not controlled by it. We note that the various dossiers have identical text based on 1,2,4-TCB, which is not necessarily relevant for the other isomers.	Thank you for your comment. Regrettably, it is not possible to change this part of the dossier in the current procedure.	
2	2010-10-13	Company,
Germany	1,2,4-Trichlorobenzene is a substance listed on Annex XVII that shall not be placed on the market, or used, as a substance or in mixtures in a concentration equal to or greater than 0.1 % by weight for any use except: as an intermediate of synthesis, or, as a process solvent in closed chemical applications for chlorination reactions, or, in the manufacture of 1,3,5-triamino-2,4,6-trinitrobenzene (TATB). Intermediates are exempted from Title VII, Authorisation. The strictly controlled and rigorously contained conditions prevent the release of the substance to the environment. There is no need for further actions.	Thank you for your comment.	
3	2010-10-13	International NGO,
International chemical secretariat,
Sweden	Its wide dispersive use should be considered and render the substance priority in further prioritizations. Textile, electronics, electric cables nad wires, paints, polishes, anti corrosion fluids, metals, dye carrier, degreasing agents, septic tank and drain cleaners, wood preservatives, and abrasive formulations, dielectric fluid, solvent, heat-transfer medium, synthetic transformer oils, lubricants, pesticide.  Sources: HSDB; Swedish EPA; US EPA; ECB	Thank you for your comment.	
4	2010-10-12	National Authority,
Health & Safety Authority,
Ireland	In Ireland, monitoring under the Water Framework Directive on 1,2,4-Trichlorobenzene (TCB) has not demonstrated a significant problem to date suggesting support for the dossier submitters indication that exposure is expected to be low. Furthermore, emissions of TCB in Ireland are less than the European pollutant release and transfer register reporting threshold of 1 kg/annum to water and 10kg/annum to air.	Thank your for this information.	
5	2010-10-11	Company,
LANXESS Deutschland GmbH,
Germany	In the EU, there is already a restriction in place prohibiting all uses of 1,2,4-Trichlorobenzene as a substance or in mixtures in concentrations above 0.1% except for use as intermediate or as process solvent in closed systems. It was already concluded in the Annex XV report that these uses are not considered to result in a release in the environment. We do not see a need for further regulatory action.  According to our knowledge, we are the only manufacturer of the substance in Europe. 1,2,4-Trichlorobenzene is already registered under REACH but we registered only for intermediate uses according to Art. 18 REACH Regulation. Manufacturing and Use take place under strictly controlled conditions. Confirmations from the buyers of the substance that the intermediate uses take place under strictly controlled conditions according to Art. 18 REACH Regulation are collected worldwide.  	Thank you for your comment.	
6	2010-09-07	Trade union,
European Trade Union confederation,
Belgium	That substance is causative agent for recognized occupational diseases in the EU See: 1) Commission Recommendation 2003/670/EC of 19 September 2003 concerning the European schedule of occupational diseases: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32003H0670:EN:HTML   The substances listed in Annex I are causative agents for diseases which have been scientifically recognised as being occupational in origin, which are liable for compensation and which must be the subject of preventive measures in all MS.     
2) "Information notices on occupational diseases: a guide to diagnosis"  http://www.beroepsziekten.nl/sites/default/files/documents/Information-Notices-2009.pdf   This document contains additional information on entries listed on Annex I of the European Schedule of Occupational diseases.  	Thank you for this information.	

Attachment

RIVM document